BEOVU

What it is

Beovu is brolucizumab solution for injection, with each millilitre containing 120 mg of brolucizumab. Brolucizumab is a humanised monoclonal single-chain Fv antibody fragment produced in Escherichia coli cells by recombinant DNA technology. Beovu is for intravitreal use only. This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

Beovu is indicated for the treatment of: — Neovascular (wet) age-related macular degeneration (AMD) — Diabetic macular oedema (DME)

Dosing overview

Beovu must be administered by a qualified ophthalmologist experienced in administering intravitreal injections.

Key safety warnings

Intravitreal injections, including those with Beovu, have been associated with endophthalmitis, intraocular inflammation, and retinal detachments. Proper aseptic injection techniques must always be used when administering Beovu. Patients should be instructed to report any symptoms suggestive of endophthalmitis, intraocular inflammation or retinal detachment without delay and should be managed appropriately. Retinal vasculitis and/or retinal vascular occlusion have been reported with the use of Beovu. These immune-mediated adverse events may occur following the first intravitreal injection. Treatment with Beovu should be discontinued in patients who develop these events. Patients with nAMD who received Beovu every 4 weeks experienced a higher incidence of intraocular inflammation and retinal vascular occlusion than patients who received Beovu every 8 or 12 week maintenance dosing. The interval between two Beovu doses during maintenance treatment should not be less than 8 weeks. Transient increases in intraocular pressure have been seen within 30 minutes of injection. Sustained intraocular pressure increases have also been reported with Beovu. Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately. Special precaution is needed in patients with poorly controlled glaucoma. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors, which include for example ischaemic stroke or myocardial infarction.

Contraindications

Beovu is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, patients with active or suspected ocular or periocular infections, and patients with active intraocular inflammation.

PBS listing

Beovu is listed on the PBS as a solution for intravitreal injection 19.8 mg in 0.165 mL pre-filled syringe with 1 PBS item. The restriction type is authority required and the ex-manufacturer price is A$885.78.

Regulatory history

Beovu brolucizumab 120 mg/mL solution for injection in pre-filled syringe and vial formulations were first listed on the ARTG on 16 January 2020. The TGA approved Beovu for the treatment of neovascular (wet) age-related macular degeneration (AMD) on 15 January 2020. In March 2021, the PBAC recommended Beovu for wet age-related macular degeneration in patients with subfoveal choroidal neovascularisation that was non-responsive to first-line anti-VEGF treatment.